When should you start a QMS?
“When do I need a Quality Management System (QMS) ?” is the most common question that we get from new clients who are just entering the medical device field. The answer depends on your target market and your exit plan. QMS is a quality management system as the name suggests this is essential for any simplest medical device too. There are two aspects of QMS. One initial is to build a system wherein you will document the system mostly as per ISO standard 13485 . System build means, writing down the procedure for each section of ISO stating what, how, when and where you are going to do. At this stage, you are only developing a strategy or system but not doing anything in action. In the second stage, you will carry out the action and create evidence of action through records of your system. This is an explanation of what QMS one must do. This is just a basic need. Then comes regulatory requirements which are different for different countries. These are must requirements, and yo...